Pessary system and method for pelvic floor ligament support

ABSTRACT

A pessary system for providing pelvic floor support for USL and other ligaments. The pessary has an elongated probe with independently inflatable balloons each located substantially the same distance from the insertion end of the probe and which inflate into separate radial sectors. The probe can be inserted into a vaginal cavity and the balloons inflated provide mechanical support to the USLs. Independent inflation of each balloon allows the mechanical USL support provided to be varied on left and right sides to compensate for differences in the degree of degradation and positioning of the USL ligaments on either side.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application Ser.No. 63,168,784 filed on Mar. 31, 2021, the entire contents of which isexpressly incorporated by reference.

BACKGROUND

Urinary incontinence is a condition that effects many women,particularly in an aging population. The symptoms of “overactivebladder” include urination urge, frequent need to urinate, nocturia, andinability to empty properly. Up to 75% of female nursing home patientsexperience some degree of urinary incontinence. Various surgical andnon-surgical treatments are used to treat this condition.

In surgical treatment techniques that are used to treat stress urinaryincontinence, existing tissue can be coapted or mechanical structuresimplanted to provide support for internal organs. One particulartreatment involves implanting a midurethral sling to provide support forthe bladder and/or urethra. For example, U.S. Pat. No. 10,426,594discloses anchoring a filamentary support element to tissues lateral tothe urethra and implanting the filament into fascial tissue to provide aligamentary support for the urethra between the first and secondlocations. The support allows existing musculature to better applypressure to the urethra.

Because surgical solutions are not available for all such conditions,and also due to risk and cost, non-surgical techniques for managingfemale incontinence are frequently used. Such techniques include use ofvaginal pessaries. Vaginal pessaries are removable devices designed tosupport pelvic organ prolapse, a condition where the bladder, rectum, oruterus drops down toward the vagina. Conventional vaginal pessaries usedfor prolapse prevention rely on placement of a pessary in the vaginalcavity to block the descent of a prolapsed organ, such as the bladder(cystocele), rectum (rectocele), or uterus (hysterocele) by acting as abarrier to descent of the prolapsed organ itself.

Pessaries can be designed for long term placement or temporary placementand removal. Long term placed configurations can cause ulceration,especially in older women. Accordingly, temporary pessaries are oftenpreferred for this type of patient.

Pessaries are available in a variety of designs. Donut or ring typepessaries are designed to surround the cervix and provide a platform inthe vagina to prevent descent. One example of an expandable pessary isdisclosed in U.S. Pat. No. 6,645,137 to Ulmsten et al. Expandablepessaries are designed for placement in the vagina where they then arespread out to form a platform that acts as a mechanical blockage to thedescending prolapse.

One type of expandable pessary is an inflatable pessary, such as shownin U.S. Pat. No. 6,470,890 to Diokno et al. A conventional inflatablepessary is designed to be inserted into the vagina in an uninflatedstate and positioned behind the pubic bone. The balloon portion isinflated to the desired amount, such as with air, water, or saline. Wheninflated, the balloon expands within a 360 degree area surrounding thepessary device to form a ball or cylinder shape around the pessary axis.The inflated balloon applies pressure to the surrounding areas in thevaginal cavity to support the prolapsed organ. Inflatable pessaries likethis are also useful for treatment of stress incontinence because theinflated balloon creates pressure on the urethra to prevent urine fromleaking out during normal activities.

Although conventional pessary designs can provide organ support andapply urethral pressure to relieve prolapse symptoms, they are notdesigned to address underlying causes of prolapses. In particular,bladder bowel and uterine prolapses, plus bladder bowel and chronicpelvic pain symptoms can be the result of loose or damaged ligaments.Deficiency in collagen, which is the main structural component of theligaments, weakens the ligaments over time so they stretch down to causeprolapse. Because the pelvic muscles contract against the ligaments, theforces which close and open the bladder and bowel also weaken, resultingin various bladder, bowel and pain symptoms. (See, Petros PE & UlmstenU., An Integral Theory Of Female Urinary Incontinence. Acta Obstetriciaet Gynecologica Scandinavica, 1990; 69; Supp. 153: 1-79.)

Accordingly, there is a need for an improved vaginal pessary thatprovides targeted mechanical support to the uterosacral ligaments andother pelvic ligaments to treat prolapse and other conditions. It wouldbe a further benefit to provide a pessary that can be used on atemporary basis and easily placed and removed by a medical practitionerand by the user. Yet a further benefit would be provided if such apessary can be easily customized to provide support for multipledifferent ligamentary areas in the pelvis. Yet an additional benefitwould be provided if such a pessary design could also be used as aplatform for support and placement of sensors and electrodes, such asfor use in EMG recording and muscle stimulation.

SUMMARY

These and other issues are addressed by an inflatable pessary system asdisclosed herein and which is configured to provide specific mechanicalsupport to loose pelvic floor ligaments to thereby support a prolapsedorgan and/or relieve other pelvic floor symptoms. Depending on placementand configuration, ligamentary support can be provided to addressprolapse of the bladder, bowel, and/or uterus. By mechanicallysupporting loose ligaments improved treatment of bladder, bowel, andpain symptoms resulting from prolapse and non-prolapse conditionsrelated to loose ligaments is also provided.

In an embodiment, the pessary system comprises an elongated flexibleprobe configured for insertion into a vaginal cavity. Two inflatableballoon portions, which can be independently inflatable, are locatedtowards the insertion end of the probe. The probe can be inserted intothe vagina to position the balloon portions at the back of the vagina,behind the cervix in the apex. Each balloon can be inflated with air orliquid, such as by use of a syringe attached to a fluid conduit leadingto the balloon. The balloons are positioned on the probe so that wheninflated they expand laterally and generally opposite to each other.When the balloons are inflated, the lateral expansion applies pressureto specific areas of the vaginal wall creating expansion pockets inthose areas of the vaginal wall, such as below the uterosacral ligament(USL), and provide mechanical support for that ligament from below. Byproviding targeted ligament support, in areas where there is ligamentweakness, expansion of the vaginal wall in other areas surrounding thepessary can be limited, reducing or avoiding over distention of thevagina and thus reducing ulceration, pain and discomfort that suchdistension may cause.

Independent inflation of each balloon allows for an asymmetricdifferential expansion of one balloon relative to the other. This allowsfor the mechanical support provided for each USL to be independentlyvaried to compensate for differences in the degree of degradation andpositioning of the USL ligaments on either side. The balloons can bedeflated and the probe easily removed on a periodic basis, e.g., toallow the vagina to revascularize and to avoid ulceration.

The lateral balloons can be formed directly on the surface of the probe.Alternatively, the balloons can be placed in an internal core area ofthe probe and the probe's core surrounded by an outer sleeve. The outersleeve can be positioned to block inflation of some of the balloonswhile others are allowed to inflate. In an embodiment, apertures areformed in the outer sleeve and the sleeve can be positioned so theapertures expose selected balloons. When these balloons are inflatedthey can expand through the respective aperture and laterally away fromthe probe. The sleeve constrains inflation of other balloons that arecovered by the sleeve Variations in the shape and size of the aperturesmay be used to provide additional control to the size, shape, andposition of each balloon as it expands. In an embodiment whereindependent balloon inflation is not required, a single balloon can beprovided in alignment with the apertures of the outer sleeve so that oninflation the balloon expands through each of the apertures whileinflation of remaining portion of the balloon is constrained by theouter sleeve.

Multiple balloons can be provided laterally along the length of theprobe core and the position of the sleeve or apertures on the outersleeve chosen to select specific balloons that can be inflated to extendfrom the probe. Each laterally placed balloon can each be coupled to aseparate conduit for providing inflation fluid so that they are allindependently inflatable. Alternatively, some or all of the balloons,such as all the balloons on a given side of the probe, can be connectedto a common fluid conduit.

In a particular implementation, a catheter-like tube with a closed endis configured with multiple weakened portions along its length, at whichpositions inflation will occur when fluid is injected into the tube. Thetube is located within the pessary and is surrounded by the outersleeve. The outer sleeve operates to allow inflation laterally outwardfrom the probe substantially only where an aperture is located andconstrains inflation in other areas. Multiple sleeves can be providedwith differently placed apertures to allow for customization of theposition of the inflatable balloons by use of an appropriate sleeve.Alternatively a blank sleeve can be provided along with suitable toolsto allow a doctor to create apertures in the sleeve at the desiredlocations.

In addition to providing ligamentary support to the respective USLs, thelateral expansion of the balloons also functions to securely anchor theprobe in place. This allows for the probe to be used for additionaland/or alternative purposes. One or more sliding sleeves carryingauxiliary balloons can be fitted onto the probe and placed so that whenthe probe is inserted and anchored with the primary balloons, theauxiliary balloons on the sleeve can be inflated below other damaged orloose pelvic ligaments, including the pubourethral (PUL), arcustendinous fascia pelvis (ATFP), cardinal (CL), and perineal body (PB),to provide support for such ligaments along with providing additionalsupport for the USL ligaments. This ligamentary support allows forselective treatment of stress urinary incontinence, cystocele, lowrectocele/descending perineal syndrome, as well as addressing bladder,bowel, and chronic pelvic pain symptoms.

Electrodes and/or sensors can be placed on the lateral balloons or otherlocations on the probe. These can be used to allow EMG recording, musclestimulation, and for other purposes. The electrode and sensor wires canbe outside of the probe or the probe configured so the connecting wiresrun within the probe.

The flexible probe can be configured with a very slim form factor,allowing it to be easily used by elderly women who typically have verynarrow vaginal cavities. The probe can also be sufficiently long tofacilitate the processes of insertion and removal, particularlyself-insertion and removal. At least the distal (non-insertion) end ofthe probe can be sufficiently flexible to allow it to be folded to allowthe portion of the probe external to the vagina to be held inside thewoman's underwear. Measurement indicia, such as marks at 1 cm intervals,can be provided on the probe to allow easy determination of theinsertion distance.

DESCRIPTION OF THE DRAWINGS

Further features and advantages of the pessary system and methods asdisclosed herein, as well as structure and operation of variousimplementations of the invention, are disclosed in detail below withreferences to the accompanying drawings in which:

FIG. 1 is a diagram of relevant anatomy of a female pelvis 100 in medialcross para-sagittal section;

FIG. 2 is a table summarizing the association between symptoms andligaments further identifying the impacted organ(s)

FIGS. 3A and 3B are illustrations of the basic features of a pessaryaccording to an embodiment in an uninflated and inflated staterespectively;

FIG. 3C shows the inflated pessary of FIG. 3B as viewed from theinsertion end along the probe longitudinal axis;

FIGS. 3D-3H illustrate different configurations of the pessary balloonsfor use in providing different types of support;

FIG. 4 is a diagram of a pessary as in FIGS. 3A-3C positioned forsupport of the USL and nerve plexuses;

FIG. 5A shows an embodiment of a pessary 500 configured forelectromyography assessment and muscle stimulation;

FIG. 5B is a diagram of the pessary of FIG. 5A in place and inflated foruse in electromyography assessment and muscle stimulation;

FIG. 5C is an illustration of a structure to mount electrodes to apessary probe of FIG. 5A according to an embodiment;

FIG. 6A is an illustration of the pessary of FIG. 3A with auxiliaryinflatable balloon sleeves;

FIG. 6B is an illustration of a pessary with auxiliary inflatableballoon sleeve positioned to provide support of cardinal ligaments;

FIG. 6C is an illustration of a pessary with auxiliary inflatablesupplementary balloon sleeve positioned to provide support of PBligaments;

FIGS. 7A and 7B show a structure of a pessary with independentlyinflatable lateral balloons in an uninflated and inflated staterespectively according to an embodiment;

FIGS. 7C and 7D show an alternative embodiment of a pessary withinflatable lateral balloons in an uninflated and inflated staterespectively;

FIGS. 8A-8D and FIG. 9 show pessary structures configured to allowcustomization of the lateral balloon positioning according to variousembodiments.

FIGS. 10A-10C show a particular embodiment of the pessary as in FIGS. 3Aand 3B; and

FIG. 11 is an illustration of an adjustable syringe mechanism for use ininflating a dual balloon pessary as disclosed herein.

DETAILED DESCRIPTION

FIG. 1 is a diagram of relevant anatomy of a female pelvis 100 in medialcross section. Illustrated is the pubic bone 102 and tail bone 104.Situated between these bones is the uterus 106, bladder 108, rectum orbowel 110, and vagina 112. The five suspensory pelvic ligaments are alsoshown. These are the Pubourethral ligaments (PUL) 122, the ArcusTendineus Fasciae Pelvis (ATFP), 124, the cardinal ligament (CL) 126,the uterosacral ligaments (USL) 128, and the perineal body (PB) 130.Also shown is the External Ligament (EUL) 120 and cervix 132, amongother features.

It has been theorized that looseness or damage to one or more of theseligaments, such as may result from collagen deficiency or othermechanisms, is the cause of bladder, bowel, and uterine prolapses, plusbladder, bowel, and chronic pelvic pain symptoms. For example, aweakening of the ligament supporting an organ can result in stretchingof the ligament downward resulting in organ prolapse. Because the pelvicmuscles contract against the ligaments, the forces that close and openthe bladder and bowel also weaken, resulting in specific bladder, bowel,and pain symptoms. The relationship between symptoms and ligamentweakness is believed to be exponential such that even a minor prolapsecan cause major symptoms. (See, Petros PE, THE FEMALE PELVIC FLOOR:Function, Dysfunction and Management, According to the Integral Theory,3^(rd) ED 2010 Springer Heidelberg.)

FIG. 2 is a diagram and chart summarizing the association betweensymptoms and particular ligaments and further identifying the impactedorgan(s). Ligaments are divided into three zones: a front zone includingthe PUL ligaments, a middle zone, including the AFTF and CL ligaments,and a back or posterior zone, including the USL and PB ligaments. Thethickness of the horizontal bar in the chart indicates a relative degreeof association with the ligament at issue according to the IntegralTheory.

With reference to FIG. 2, ligament weakness in the anterior zone (frontligaments) can result in stress urinary incontinence (SUI) but alsobladder frequency, urgency, and fecal incontinence when associated withSUI. Ligament weakness in the middle zone (middle ligaments) can resultin cystocele prolapse with associated symptoms of emptying, urgency, andchronic bladder infections. Ligament weakness in the posterior zone(back ligaments), including the USL ligaments, can result in uterineprolapse, apical if there has been a hysterectomy, enterocele, and highrectocele when the USLs are laterally separated. Associated symptoms ofUSL laxity include abnormal emptying of bladder and bowel, urgency to goto the toilet, inability to evacuate (bladder and bowel), nocturia,frequent need to evacuate, and chronic pelvic pain.

FIGS. 3A and 3B are illustrations of the basic features of an improvedpessary 300 according to an embodiment and which can providecontrollable mechanical support targeting uterosacral ligaments tothereby reduce symptoms and pain associated with or without bladder,bowel, and uterine prolapses. FIG. 3A shows the pessary 300 in anuninflated state and FIG. 3B shows pessary 300 of FIG. 3A in an inflatedstate.

Turning to FIGS. 3A and 3B, the pessary 300 comprises elongated flexibleprobe 310 that extends along a longitudinal axis 302. The probe 310 canbe made of rubber, silicon rubber, or other flexible material that isbiocompatible and safe for internal use. Suitable materials are known tothose of skill in the art. The probe 310 is configured for insertioninto a vaginal cavity and has an insertion end 315 and a distal end 320.The probe 310 has first and second inflatable portions 325, 325′. Eachinflatable portion 325, 325′ (alternatively referred to as a balloon) isa predefined distance, such as D1, from the insertion end 302. Eachinflatable portion 325, 325′ is in fluid communication with a respectivefluid conduit 330, 330′.

In this embodiment, balloons 325, 325′ are independently inflatableusing fluid, such as air, water, or saline, introduced into therespective conduit 330, 330′. Independent inflation allows the balloons325, 325′ to be inflated to different degrees. Such differentialexpansion advantageously allows the pessary 300 to provide more precisemechanical support for respective ligaments, such as the USL, where oneligament is generally located more lateral than the other. In addition,differential inflation allows compensation for differential elasticityin the back part of vagina by allowing the distension from theinflatable portions 325, 325′ to expand the vagina asynchronously. Thisreduces the possibility of excessive one-sided pressure that canulcerate the vaginal wall. In an alternative embodiment, the lateralballoons may be coupled to the same fluid source and inflate together.

Various ways to provide fluid and inflate portions 325, 325′ can beused. In one embodiment, a syringe (not shown) is connected to arespective conduit 330, 330′ via a valved luer lock or other coupler335, 335′. Other appropriate couplers 335, 335′ are known to those ofskill in the art. The amount inflatable portions 325, 325′ expand isdependent on the design of the inflatable portions and the amount ofinjected fluid. For example, in a particular embodiment, the balloonscan be independently inflated with up to 5 ml or up to 10 ml of liquideach. Of course, different inflation amounts may be used depending onthe size of the balloons and the degree of desired inflation.

The fluid conduits 330, 330′ can be physically separate tubes and may besurrounded in whole or part by an outer casing, such as larger tubethrough which conduit tubes pass. Conduits 330,330′ can be formed aschannels that are integrally formed within a single tube. A combinationof separate conduit tubes and integrated conduits may be used as well.Such as outer casing or tube with integral conduits may have the same ordifferent width as the probe 310. For example, the casing may have asmaller diameter than the pessary probe. A particular embodiment withthe fluid conduits integrally formed within a tube is shown in FIGS.10A-10C discussed below.

The probe has a length L from the insertion end 315 to the distal end320 and which is long enough to allow for full insertion of the probe310 into a vaginal cavity and proper placement. In an embodiment, aportion of the probe remains external to allow for manipulation. A probedesigned for insertion and removal by a third party, such as a doctor ornurse, may be shorter than one designed for self-insertion and removal.For example, the length L can be between 20 cm and 60 cm, between 30 cmand 50 cm and about 40 cm long or greater. In a particular embodiment,the pessary 300 has a length L sufficient so that when fully insertedinto the vagina, a sufficient length of probe remains outside of thevagina to allow for a doctor to easily manipulate the position of theprobe. For example, after insertion to the appropriate position theportion of the probe 310 outside of the vagina can be longer than theportion inside of the vagina. Pessary 300 can be configured so that theend portion 320 can be cut to adjust the length, after which couplers335, 335′ may need to be connected to cut ends of the fluid conduits330, 330′. In a further embodiment, the pessary length L is selected sothat only a small portion or even none of the pessary probe 310 remainsexternal after insertion. The ends of the inflation conduits may remainexternal and provide a grasping means to extract the pessary.

The probe has a width W which can be relatively small to thereby providea slim probe configuration allowing the pessary probe 310 to easilyenter into the vagina even in the oldest woman with the narrowestvagina. Such a slim form factor is especially useful where the probe isfor use in treatment of bladder and bowel problems in the frail womenwho inhabit nursing homes, 75% of whom have major bladder/bowelsymptoms. In a particular configuration the probe 310 can have a widthof between 1.5 cm and 1.6 cm. Other widths are also possible. Forexample the width W can be between 1.3 cm and 1.7 cm and between 1 cmand 2 cm. The probe can be fabricated with even narrower or widerwidths, although wider widths may be more difficult to insert forcertain patients.

The cross-sectional shape of the probe can be any suitable shape,including round, oblong or rounded rectangular. The cross-sectionalshape may be selected to accommodate supplemental sleeves with auxiliary“blow up” balloons, discussed further below, allowing the sleeves toslide onto the probe and be manually positioned laterally whilerestricting axial rotation of such sleeves. The cross-sectional shapemay also be selected to assist with placement orientation of the pessaryprobe for a woman to easily self-insert.

The probe width and shape does not need to be constant along the entirelength of the probe 310. For example, the width of the probe 310 in theportion intended for vaginal insertion may be narrower than the portionintended to remain external or visa versa. In another embodiment, thevaginal insertion portion may be wider than the external portion. Thus,the insertion end could have a width within one of the ranges rangenoted above while the distal end is be larger to allow for easiermanipulation of the probe and attachment of inflation syringes.Similarly, the cross-sectional shape may be different in differentlocations along the length of the sleeve. For example, the insertion endmay have a round cross section to provide for easy insertion while thedistal end has another shape, such as generally oblong, rectangular,triangular, or trapezoidal, and which allows the internal orientation ofthe probe to be easily determined by feel at or near the distal end.

A long pessary configuration, such as one with length of 40 cm orgreater, facilitates the process of inserting and removal of the probe,filling and emptying the lateral balloons with fluid, with differentialvolumes for each if required. As noted, the probe 310 can be flexiblealong its length. The degree of flexibility may vary along the length ofthe probe 310, such as based on internal structures. The flexibility ofthe probe 310, allows a woman to easy self-insert and inflate thepessary 300. In a particular embodiment where more than a minimal aportion of the pessary remains external to the vagina after fullinsertion, such as more than 1 cm to 2 cm, the external portion isflexible enough so it can be bent and held in whole or part inside thewoman's underwear during use. As noted above, in a configuration wherethe pessary probe is fully or substantially internal, portions, such asfluid conduit(s) used for inflation may extend a further distance. Theconduits can be made of a conventional flexible tubing wherein thisportion of the pessary can be bent to remain within the woman'sunderwear.

FIG. 3C shows the inflated pessary 300 of FIG. 3B as viewed from theinsertion end 315 along the longitudinal axis 302. As illustrated inFIG. 3C, in this embodiment each inflatable portion 325, 325′ expandslaterally outwards from the probe 310 when inflated. With considerationto a circular area centered on and normal to the longitudinal axis 302,the first inflatable portion 325 inflates into a first radial sector 350relative to the longitudinal axis 302 of the probe 310. The secondinflatable portion 325′ when inflates into a second radial sector 350′relative to the longitudinal axis 302. The width of each sector isdependent on the geometry and maximum inflated size of the inflatableportions 325, 325′. The specific angular placement and width of thesectors can be selected with consideration of the anatomical location ofthe ligaments to be supported relative to the vaginal wall.

Placement of the pessary 300 is discussed with respect to FIG. 4 whichshows a pessary 300 positioned for support of the USL. The probe 310 ofthe pessary 300 is inserted into the vagina until the inflatable areas325, 325′ are in the back part of the vagina behind the cervix and theuterus 106. As the inflatable areas 325, 325′ are inflated, they expandlaterally as discussed above, pressing against the vaginal wall andcreating expansion pockets in those areas. These pockets, as maintainedby the balloons, provide ligamentary support.

In a particular configuration, the lateral position of the balloons isselected so that they each expand to position the expanded pockets ofthe vaginal wall below the uterosacral ligaments (USL) 128. Bysupporting the USLs, the pessary 300 can be used to help prevent uterineprolapse.

Also shown in FIG. 4 is nerve plexus (NP) 410 is anatomically supportedby the USL 128, one on each side. NP 410 represents the sympathetic(T11-L2) and parasympathetic sacral (s2-4) situated about 2 cm from theinsertion point of the USLs as they enter the lateral part of thecervix. Use of the pessary 300 puts the inflatable portions 325, 325′ inthe region of the NP 410. Sagging of the NP 410 can cause the nerves tofire and produce chronic pelvic pain which is then referred to thetarget point of specific nerve fibres (vagina=vulvodynia;bladder=interstitial cystitis; lower abdomen=dragging abdominal pain;sacral area=coccydynia; paraurethral=“muscle spasm” and so on). Theinflated balloons provide support for the NP 410 to prevent or reducesagging of NP to alleviate associated pelvic pain, such as the painslisted above.

The probe 310 also mechanically reinforces the USLs to provide a firmanchoring point for the backward/downward directional muscle forceswhich stretch the vagina to provide underlying support for the bladderbase and anorectal stretch receptors. If the bladder base and anorectalstretch receptors are unsupported, this may result in prematureactivation of the micturition and defecation reflexes which areperceived by the patient as bladder/bowel “urge incontinence” and anight “nocturia”. In addition, the same ligaments anchor the muscleswhich stretch open the urethra and anorectum to facilitate evacuation ofurine and feces. This is perceived as urinary retention andconstipation.

As noted, different lateral expansion of the balloons can be used toprovide targeted support of different structures. Turning to FIGS.3D-3H, lateral placement for use in supporting different structures isdiscussed below with reference to a 12-hour clock face with thelongitudinal axis 302 in the center of the face, with the 12:00 pointdorsally oriented and the clock face generally sagittal oriented. Whilea sector is defined by a maximum design inflation, an inflatable portionthat is not fully inflated does not need to fill its expansion sector.Thus, an inflatable portion with an expansion sector from 9:30-11:30could when inflated to a desired amount a fill just the 10:00-11:00sector. Inflatable portion 325, 325′ can also be sized and positioned toprovide combinations of ligamentary support.

FIG. 3D illustrates balloons 325, 325′ positioned to expand (when thepessary is inserted and positioned as appropriate) against the anteriorvaginal wall with expansion sectors between 9:30-11:30 and 12:30-2:30respectively to provide support to pubo urethral ligament at mid urethrawith support balloons to each side of urethra. FIG. 3E illustratesballoons positioned to expand against the anterior vaginal wall behindthe pubic bone with expansion sectors between 9:00-11:00 and 1-3:00 thatextend posteriorly to provide support to the Arcus Tendinous FasciaPelvis and insertion points of the levator muscles. FIG. 3F illustratesballoons positioned to expand against the posterior vaginal wall about1-3 cm from the vagina introitus with expansion sectors from 7:00-10:00and 2:00-5:00 to provide support for the deep transversus perineiligament. FIG. 3G illustrates balloons positioned to expand against theanterior vaginal wall in the region of the anterior surface of thecervix with expansion sectors from 8:00-10:00 and 2:00-4:00 to providesupport to the Cardinal Ligament (e.g., to treat high cystocoele ortransverse defect). FIG. 3H illustrates balloons positioned to expandagainst the anterior vaginal wall posteriorly behind the cervix withexpansion sectors from 9:30-12:00 and 12:00-2:30 to provide support forthe insertion points on the Utero sacral ligament.

In the embodiments above, the expansion sectors are spaced apart fromeach other such that balloons filling the sector will not touch whenfully inflated. In a further embodiment, the balloons 325, 325′ can bepositioned so that the expansion sectors are adjacent and whereininflated balloons can touch. This embodiment may be useful, for example,to create a combined pocket in the vaginal wall that provides continuoussupport from one sector to the next, and where the independent inflationof the balloons allows for adjustment of the degree of support providedon each side of the combined sector. (See FIG. 3H) In general, thesectors will be adjacent or spaced apart but will not overlap. However,in an alternative embodiment, inflatable portions 325, 325′ could beshaped and placed so that there is least some overlap. The relativeposition of the expansion sectors 350, 350′ to each other can bespecified by an angle between the midline of each sector. For example,the sectors can be positioned so sector midlines are between 90 and 180degrees apart, or between 120 and 180 degrees apart where the sectorsare at least generally opposite to each other, or at substantially 180degrees apart resulting in sectors that are substantially opposite eachother. It should be appreciated that the position of each sector canalso be defined with other references, such as with respect to a+/−angle of rotation from the sagittal plane of the probe.

In sum, both the angle between each of the sectors and the angular widthof each sector can be defined to position the balloons to provide thedesired ligament support while limiting pressure on the vaginal wall inother areas around the pessary where support is not needed.

To allow for proper placement of the inflatable portions 325, 325′within the vagina, the distance D1 from the insertion end 315 of theprobe to the inflatable portions can be selected to be the expecteddistance from the back of the vagina to the desired placement positionof inflatable portions 325, 325′ behind the uterus. Fully inserting theprobe 310 will put the inflatable portions 325, 325′ in the correctposition. Alternatively, distance D1 can be less than the expecteddistance from the desired position of the inflatable portions 325, 325′and the back of the vagina. The probe 310 can have indicia markingdistance intervals, such as at 1 cm intervals, and this marking can beused to gauge when the probe has been inserted the correct amount and tohelp gauge orientation to place the inflatable portions 325, 325′ asdesired, such as behind the uterus and to the side of the USLs 128. Theproper insertion distance can be determined during a medical exam andcommunicated to the patient for reference during later self-insertion.Other techniques are also possible. For example, a doctor may fit agiven pessary 300 to a patient and then add an indicia to the probe 310to indicate the proper length to be inserted. In addition, as discussedfurther below with respect to FIGS. 8A-8D and FIG. 9, a pessary systemcan be provided in which the distance from the insertion end to thelateral inflatable portions is configurable so that when the pessaryprobe is fully inserted, the inflatable portions are in the properlocation for the specific patient so as to provide USL or other support.

Advantageously, a pessary 300 as disclosed herein can be usedintermittently and be easily self-inserted. For example a woman canself-insert and inflate the pessary 300 for use during the day and theneasily deflate and remove it at night. This allows the vaginal tissue torest and be revascularized, significantly reducing the propensity forulceration. The pessary 300 can be used when going out to a socialoccasion but removed when the patient is at home. If used for nocturia,the pessary 300 can be removed for intercourse, and reinsertedafterwards so as to control nocturia through the night. If used tocontrol symptoms such as chronic pelvic pain, which can cyclically varyfrom mild to very severe, sometimes in the space of a few days, thepessary 300 can be inserted only when the pain is cyclically severe. Itcan also be inserted to assist in passing urine and then removedafterwards.

FIG. 10A is specific embodiment 1000 of the pessary 300 discussed above.

Pessary 1010 has a probe body 1010 with first and second inflatableportions 1025, 1025′. The inflatable portions 1025, 1025′ are fed byrespective conduits 1030, 1030′ which pass through a tube 1031 and intothe probe body 1010. An indentation 1090 or other tactile element on oneside of the probe body 1010 lets a person holding the probe easilydetermine the probe's orientation. Element 1090 can also be configuredto allow for a more secure grip on the probe body 1010 during insertionand removal. The conduits 1030, 1030′ can be terminated with valved luerlocks 1035, 1035′. One conduit can extend further than the other and/orjut out at an angle to provide a clear indication of which conduit feedswhich inflatable portion.

FIG. 10B is an illustration of a cross section of probe body 1010 alongline B-B. The probe 1010 in this embodiment has a flattened shape with athickness W1 and a width W2 that is greater than W1, such as between 1.5and 2.5 times greater. The conduits 1035, 1035′ are integrally formedwithin at least a portion the probe body 1010, such as by molding theprobe body 1010 around separate conduit tubes or through an extrusionprocess. A central area 1040 of the probe body 1010 can be hollow toform a void. Having such a void can increase the flexibility of theprobe for a given fabrication material and also reduce weight.

FIG. 10C is an illustration of a cross section of tube 1031 along lineC-C. Similarly, and with reference to FIG. 10C, conduits 1030, 1030′ canbe integrally formed within at least a portion of the tube 1031. Acentral area 1045 of the tube 1031 can be hollow.

In one embodiment, the hollow void 1040 in the probe body is closed offso that the internal air or other fluid is trapped within. Likewisehollow void 1045 can be closed or open and may be connected to orseparate from void 1040. In a variation, pessary 1000 can be configuredso that air or other fluid can be selectively introduced to the void1040, such as through an auxiliary valve (not shown). Adjusting thepressure of air in the void 1040 can increase or decrease the stiffnessof the probe body 1010. In an exemplary embodiment, the probe body 1010has a thickness W1 of about 5 mm and a width W2 of about 10 mm.

FIG. 10A shows the inflatable portions 1025, 1025′ in a partiallyinflated state and shows a maximum inflation state in dotted line.Inflatable portions can be configured to inflate to an inflationdiameter ID1 perpendicular to the probe axis of between 21 mm and 30 mmand a diameter ID2 measured along an axis parallel to the main axis ofthe probe of between 21 mm and 30 mm. The probe body can be provided inone or more lengths. For example, the forward portion 1015 of the probebody 1010 can be offered with a length L1 of between 80 mm and 90 mm,such as 85 mm, or a length of between 90 mm and 100 mm, such as 93 mm or95 mm. A rear portion 1016 of the probe body is tapered with length L2.In an exemplary embodiment, L2 is between 5 mm and 10 mm, such as 7 mm.An outer diameter of tube 1031 can be between 3 and 5 mm, such as 4 mmor 4.2 mm. The channels 1030, 1030′ can each have a diameter between 0.5mm and 1.0 mm, such as 0.8 mm.

FIG. 5A shows a further embodiment of a pessary 500 configured forelectromyography (EMG) assessment and muscle stimulation. Pessary 500 issimilar to pessary 300 shown in FIGS. 3A-3C, above, and includes a probeportion 510 with an insertion end 515 and laterally positionedinflatable portions 525, 525′. In this embodiment, one or both of theinflatable portions 525, 525′ can include electrodes, such as electrodes560, 560′. Electrodes 560, 560′ can be used as electrical sensors and/orsites for applying electrical stimulation to surrounding tissue. Wires565, 565′ electrically connect the electrode 560, 560′ to appropriatecircuitry 562, such as an EMG sensing signal display and/or analysissystem, a muscle stimulation device, or other circuitry as desired.While only one electrode 560, 560′ is shown on each inflatable portion525, 525′, more than one electrode can be present. For example, eachinflatable portion 525, 525′ could have two electrodes, one for EMGsensing of electrical activity in surrounding muscle tissue and one forstimulating surrounding muscle tissue. Other equipment, such as apressure sensor, could also be mounted on an inflatable portion 525,525′. Such inflatable portions 525, 525′ in a pessary 500 used for EMGassessment and stimulation may be more robust than similar inflatableportions 325, 325′ in pessary 300 as discussed above.

In use, the inflatable portions 525, 525′ carrying the EMG electrodesare inflated, e.g. with air, and expand laterally. With the pessaryappropriately positioned, this expansion brings the EMG electrodesdirectly over the pelvic muscles on each side, such as the pubococcygeusmuscles. The expanded balloons sit securely over the muscles whileelectrical recording or stimulation occurs. FIG. 5B shows a pessary 500of FIG. 5A, inserted and with the inflatable portions 525, 525′expanded. These laterally expand the elastic vaginal wall 575 (situatedpast the lateral vaginal wall 576) to position the EMG electrodes 560,560′ adjacent the puboccygeus muscles 580, 580′.

The electrodes 560, 560′ can be integrally formed with the inflatableportion 525, 525′ during manufacture. Alternatively, the electrodes 560,560′ can be separately mounted onto the inflatable portions 525, 525′,either during manufacture or at the time of use. The wires 565, 565′connected to electrodes 560, 560′ can be routed within the probe 510 oralong its exterior.

There are various ways to attach the electrodes or other sensorequipment to the pessary 500. In one embodiment, the component isattached using an adhesive. In an alternative, and with reference toFIG. 5C, the electrodes can be formed on an elastic sleeve 570 which isconfigured to slide onto probe 510 and be placed along the probe toposition the electrodes on the sleeve adjacent the inflatable portions525, 525′. Sleeve 570 is shown in FIG. 5C as an open-ended cylinder.Alternatively one end could be closed, in full or part, so that thesleeve 570 can only be slid down on the probe 510 until the insertionend of the probe reaches the closed end of the cylinder. The dimensionsof sleeve 570 and placement of electrodes can be selected so that whenthe sleeve is mounted on probe 510 to its full extent this places theelectrodes in a known and desired position. The use of the open sleeve570 can allow placement of the electrode(s), sensors, or other equipmenton the sleeve 570 at a variety of locations along the length of theprobe 510. Indicia can be provided on the probe, such as indicating anumber of centimetres from the insertion end of the probe 510, to allowfor placement of the sleeve 570 in a specific position on the probe 510so as to result in the electrodes being placed at the desired locationwhen the pessary 500 is in use.

While independently inflatable balloons 525, 525′ are shown, in analternative embodiment, the balloons 525, 525′ can be connected to acommon fluid conduit and be inflated simultaneously.

According to a further embodiment, and with reference to FIG. 6A,inflation of the inflatable portions 325, 325′ firmly anchors the probewithin the vaginal cavity. This allows the probe 310 to be used as aplatform for additional supporting balloons. One or more auxiliarysleeves 625 can be placed onto the probe 310 at desired locations. Eachsleeve 625 comprises an inflatable balloon 628 that can be inflated viaa respective fluid conduit 630. In a typical embodiment, an auxiliarysleeve balloon 628 will inflate symmetrically into a ‘donut’ shapealthough other configurations are possible. The auxiliary sleeve balloon628 can be a single chamber or can be bifurcated or otherwise configuredso that only portions inflate.

The sleeve 625 is configured so it can be manually positioned along theprobe 310, e.g., by sliding it up and down, but is sufficiently tight sothat it will remain in a set position on the probe when the pessary isinserted for use. Inflation of the balloon 628 may further lock thesleeve 625 into position on the probe 310.

A given auxiliary sleeve 625 can be precisely placed within the vaginalcavity by positioning the sleeve on the probe 310 at a specificlocation, such as with reference to distance indicia 640. A sleeve 625can be placed along the probe 310 to introduce an auxiliary balloon 628to provide mechanical support for additional damaged or loose pelvicligaments and to treat specific conditions. For example, support can beprovided to the PUL, ATFP, CL, USL, and PB ligaments. As discussed abovewith respect to FIG. 2, weakness in these ligaments is believed to be asignificant cause of organ prolapse such as bladder (cystocele), bowel(rectocele, descending perineal syndrome), and uterine/apical prolapsePLUS bladder/bowel/chronic pelvic pain symptoms.

By way of example, and with reference to FIG. 6B, an auxiliary balloonsleeve 625 can be positioned on the probe 310 so that the auxiliaryballoon 628 is precisely placed within the vaginal cavity immediately infront of the cervix 105 while the remainder of the probe 610 passesunder the uterus 106 to rest in the posterior fornix of the vagina. Theinflatable portions 325, 325′ can provide support to the USL asdiscussed above. The auxiliary balloon 628, when expanded, can providemechanical support to the cardinal ligaments 132 as they insert into theanterior cervical ring. Such an auxiliary balloon can be used forsupport of a “high cystocele” (transverse defect). In an embodiment, theauxiliary balloon 628 is configured so it does not encircle the cervix.In an embodiment with reference to FIG. 6B, where the auxiliary balloon625 is used to provide support to the cardinal ligaments, the ballooncan have a donut-like shape and be sufficiently large as to surroundcervix and be able to be pushed onto the anterior lip of cervix. Thesleeve 625 can have at least one solid section 626 which does notinflate and functions to prevents the auxiliary balloon 628 frominflating a substantial amount upwards but instead inflates primarilylaterally to support the two ends of the dislocated cervical ligament.In an embodiment two solid sections 626 are used and positioned onopposite sides of the probe so that the inflated balloon 628 when viewedaxially will be generally shaped like the number 8.

Similarly the auxiliary sleeve 625, or additional sleeves, can be placedfurther down on the probe to support the pubourethral ligamentanteriorly (for SUI) and rectocele and perineal body posteriorly. Theballoon 628 can be bifurcated, so one part goes up each side to supportthe ligamentous structure. This format has the advantage of not blockingthe urethra for micturition or the bowel for defecation. FIG. 6C is anillustration of an auxiliary balloon sleeve 625 with a bifurcatedballoon 628 of FIG. 6B and that is positioned to support the two deep PBligaments 130.

There are various ways in which a pessary with inflatable lateralballoons as disclosed herein can be structured. A particular embodimentof a pessary 700 is shown in FIGS. 7A and 7B in an uninflated andinflated state, respectively. In this configuration, a pair of fluidconduits, such as lumens 730, 730′, is contained within an outer sleeve710. Each fluid conduit 730, 730′ has a respective inflatable balloonportion 725, 725′ formed on it. The fluid conduits 730, 730′ can be madeof an elastic material and inflatable portions 725, 725′ can be formedas a weakened or thin area of the respective conduit wall.Alternatively, the inflatable portions 725, 725′ can be in the form ofan inflatable donut which is affixed to and in fluid communication withthe respective fluid conduit. In a particular embodiment, each fluidconduit 730, 730′ and respective inflatable portion 725, 725′ thereon isstructured in a manner similar to that of a conventional ballooncatheter, although the guidewire is not required.

The outer sleeve 710 has respective apertures 712, 712′ which arealigned with the inflatable portions 725, 725′. During inflation, theballoon portions 725, 725′ expand laterally outwards though therespective apertures 712, 712′. While the balloon portion 725, 725′ of asingle conduit 730, 730′ if inflated outside of the pessary may tend toexpand into a donut or ball shape, the expansion of each balloon portion725, 725′ in the pessary 700 is constrained by outer sleeve 710 andpressure from the other balloon portion and/or fluid conduit.

In an alternative embodiment where independent inflation is notrequired, a single balloon can be provided, such as would naturallyinflate in a torus shape around a tube used for inflation. Apertures inthe outer sleeve allow directed inflation in the desired axial locationswhile inflation in other areas is constrained. Such an embodiment isshown in FIGS. 7C and 7D. Pessary 750 has a balloon portion 755inflatable via fluid conduit 760. Outer sleeve 710 with apertures 712,712′ is positioned to align the apertures with the balloon 755 andthereby define areas of the probe 750 in which the balloon 755 canexpand laterally.

FIG. 8A shows a further embodiment 800 in which the position of thelaterally inflatable portions relative to the insertion end can beselected from two or more predefined positions to allow for customfitting to a given patient. In this configuration, each fluid conduit830, 830′ can operate as a manifold to feed multiple inflatable portionsalong the length of the probe 810. For example, conduit 830 feedsinflatable portions 825 a and 825 b located a distance D1 and D2 fromthe insertion end 815. Likewise, conduit 830′ feeds inflatable portions825 a′ and 825 b′. An outer sleeve 835 can be positioned along thelongitudinal axis of the probe so that it covers one pair of inflatableportions, 825 a, 825 a′ or 825 b, 825 b′ while the other pair is leftuncovered. During an inflation action, the uncovered pair of inflatableportions will inflate while the sleeve 835 constrains inflation of thecovered pair. Multiple sleeves can be used on the probe to selectivelyblock inflation of additional inflatable portions on the probe ifpresent.

FIG. 8B is a variation of the embodiment of FIG. 8A in which an outersleeve 840 is configured to be slipped over the probe 810 and has one ormore apertures, such as apertures 845, 845′. The sleeve 840 can bepositioned on the probe 810 so that each aperture 845, 845′ exposes aselected inflatable portion, such as inflatable portions 825 a, 825 a′while other inflatable portions are covered by the sleeve. When fluid isintroduced into the conduits 830, 830′, the inflatable portions 825 a,825 a′ exposed by the apertures 845, 845′ can inflate and expandlaterally beyond the outer sleeve 840 while other inflatable portions825 b, 825 b′ are restricted by the outer sleeve 840 and confined withinthe sleeve 840. Depending on the overall geometry of the pessary 800, asingle outer sleeve 840 may be positionable along the probe 810 toexpose one pair 825 a, 825 a′ or the other pair 825 b, 825 b′ ofinflatable portions. Alternatively, the pessary 800 can be provided withmultiple outer sleeves 840 each with apertures positioned to align witha selected pair of inflatable portions. The sleeve 840 and apertureplacement thereon may also be configured so that the sleeve orientationcan be reversed so that with the sleeve in the same position on theprobe, the exposed inflatable portions are determined by whether a firstend of the sleeve is closest to the insertion end of the probe orclosest to the distal end of the probe.

FIG. 8C is a variation of FIG. 8B in which the inflatable portions 825a, 825 a′, 825 b, 825 b′ are formed along the length of a respectivefluid conduit 830, 830′. Analogous to FIG. 8B, the probe 850 hasapertures 850 a, 850 a′, 850 b, 850 b′ which expose the respectiveinflatable portions allowing for lateral expansion. Outer sleeve 840 ispositioned along the length of the probe 850 to place the apertures 845,845′ in the outer sleeve 840 adjacent the inflatable portion positionedin the desired location. When fluid is introduced into a given fluidconduit, such as conduit 830, all of the inflatable portions along itslength will be subject to inflation. However, only the inflatableportions adjacent the respective aperture in the outer sleeve 840 canexpand laterally outwards from the probe while inflation of the otherinflatable portions is restricted by the outer sleeve.

Yet a further variation of this embodiment is shown in FIG. 8D. In thisconfiguration, rather than having multiple separate inflatable portionsalong a length of a fluid conduit 830, 830′, the fluid conduit has anelongated inflatable portion instead, such as elongated inflatableportions 860, 860′. The position of lateral inflation relative to theinsertion end is governed by the position of the external sleeve 840 andthe apertures 845, 845′ therein.

In a further alternative and with reference to FIG. 9, pessary 900 has amain probe body 910 with inflatable portions 925, 925′ inflatablethrough respective fluid conduits 930, 930′. Inflatable portions can beintegral to the probe body 910 or formed on internal lumens or otherconduits and positioned adjacent apertures in the probe body 910.Differently sized end-caps, such as end caps 915 a, 915 b can beprovided to allow selection of the desired distance between theinflatable portions 925, 925′ and the insertion end of the pessary 900at the desired position when the pessary 900 is fully inserted. Forexample, use of end cap 915 a positions the inflatable portions 925,925′ a distance D1 from the insertion end and use of end cap 915 bpositions them a distance D2 from the insertion end.

The end caps 915 a, 915 b can be mountable to the probe body 910 by avariety of mechanisms. For example, end caps can be somewhat elastic andmounted using a friction fit to the probe body 910. Mechanical retainingstructures, such as detents 935 configured to engage the apertures inthe probe body 910 or other structures on the probe body can be used toprevent removal. Various other retention mechanisms known to those ofskill in the art can be used. In a further variation, the pessary systemis configured so that the mounting position of a single end cap alongthe probe body is selectable to thereby allow adjustment of the distancebetween the insertion end and the inflatable portions 925, 925′. Forexample, the end cap and probe body can be configured so the end capwill snap fit into two or more different positions. Other mechanismsknown to those of skill in the art that allow an adjustable mountingposition can also be used.

As discussed with other embodiments, if independent lateral inflation ofthe balloons is not required, the dual balloon/inflation conduitstructure of FIGS. 8A-8D and FIG. 9 can be replaced with a singleballoon and inflation conduit. According to a further embodiment,various methods for providing pelvic floor ligament support treatingprolapse and descending perineal syndrome), uterine/apical prolapse,bladder/bowel/chronic pelvic pain symptoms, and other conditions areprovided.

In one treatment a pessary, such as pessary 300 as in FIG. 3A, isprovided and inserted into the vagina, such as by a physician or a user,to place the inflatable portions of the pessary behind the cervix. Thismay entail inserting the pessary its fullest extent or inserting it lessthan the full amount. If inserted less than the full amount theinsertion measurement can be initially be recorded during a fitting by aposition to allow for subsequent self-insertion by the patient the sameamount. (The insertion measurement distance could also be recorded andcommunicated to the patient even if full insertion is desired.)

The balloons are then independently inflated an amount sufficient tobring each balloon below the respective USL. The proper amount ofinflation can be determined by the treating physician, for example basedon the degree of pain relief or reduction in urgency provided as theballoons are inflated. Alternatively if there is significant prolapse,an appropriate amount of inflation can be determined by inflating andtesting if the balloon is holding fast and when the fit is secure, theamount of fluid required for each side can be noted. The amount ofinflation required can also be determined by the patient based on thedegree of pain relief or reduction in urgency provided as the balloonsare inflated.

A measure of inflation volume is also recorded and can be communicatedto or recorded by the patient so that the patient can subsequentlyperform a self-insertion method of treatment and can inflate eachballoon the appropriate amount. For example, fluid can be introduced bya syringe or other mechanism that has indicia providing a measurement ofthe volume of fluid introduced. The indicia can be used to measure thefluid amount introduced by the physician and used by the patient selectthe volume of fluid used to inflate the respective inflatable portion325, 325′.

A single syringe can be used sequentially to introduce a predefinedvolume of fluid into one conduit 330 and then then other conduit 330′ toinflate the inflatable portions 325, 325′ in turn. Alternatively, twosyringes can be connected to respective conduits 330, 335′ to allowsimultaneous inflation. Instead of an initial fluid injection by volume,air can be injected until a predefined pressure is reached, at whichpoint the volume of air injected can be recorded for later use. The twosyringes can be ganged together or physically separate from each other.In a ganged configuration, the syringe plungers can be separatelydepressible or they can be connected to each other so they must bedepressed simultaneously.

In a further configuration, adjustable constant volume syringes can beprovided so that the total amount of fluid injected when each plunger isdepressed the full amount can be set to the desired volume. The syringescan be configured by the doctor during the initially pessary fittingsession to set the appropriate fluid injection volume. The totalinjection volume can be configured, e.g., by adjusting the length of theplunger stem that can be inserted into the syringe. For example, theplunger tips can be attached to the stems by a threaded or slidable rod.Suitable adjustment mechanisms for constant volume syringes are known tothose of skill in the art.

In a particular embodiment, shown in FIG. 11, a pair of adjustableconstant volume syringes 1102, 1102′ are provided, each having a plunger1104, 1104′ with a respective plunger tip 1106, 1106′ and adjustablelength stem 1108, 1008′. The two syringes 1102, 1102′ can be physicallyconnected to each other and configured so the ends 1110, 1110′ of theplungers can both be connected to an injection coupler 1120 which putseach syringe in fluid connection with a respective inflation conduit.The conduit coupler and syringes can be configured so that each syringeonly be fitted to the injection port of the coupler 1120 for the pessaryballoon for which the syringe volume is set.

Where the pessary is configured as in FIGS. 8A and 8B, the method oftreatment can further include the step of selecting from a plurality ofapertures at different varying locations along the probe one or moreinflatable apertures at particular distances from the insertion end ofthe probe from by placing an outer sleeve 840 with apertures 845, 845′onto the probe 810 and positioning it so that the apertures expose theselected inflatable portions while the sleeve restricts inflation ofother such portions. The method can include the step of receiving thepessary with a plurality of outer sleeves each of which has apertures indifferent locations and selecting a particular sleeve from a pluralityof sleeves. The method can include the step of receiving the pessary andan outer sleeve, forming apertures in the sleeve at a selected locationon the sleeve, and then placing the sleeve on the pessary so theapertures expose selected inflatable portions.

Where the pessary is configured as in FIGS. 8A and 8B, the method oftreatment can further include the step of selecting an outer sleeve 840with apertures 845, 845′ therein and positioning the sleeve onto theprobe so that the apertures are positioned a particular distance fromthe insertion end so as to adjust the axial position of where theinflatable portions will laterally expand when inflated.

Where the pessary is configured as in FIG. 9, the method of treatmentcan further include the step of adjusting the distance between theinflatable portions and the insertion end of the probe by placing aselected endcap onto the pessary probe body 910. The method can includereceiving the pessary with a plurality of differently sized end caps andselecting the particular end cap from them.

In a further method of treatment, an auxiliary balloon sleeve is fittedto the pessary, such as by the physician. The sleeve is positioned onthe pessary so that when the pessary is inserted the specified amount(such as fully or a defined length as discussed above), the balloon onthe sleeve will be positioned to provide auxiliary ligament support.

In a particular method for positioning the sleeve, the sleeve isconfigured to fit loosely on the pessary probe 310. A firm anchoring ofthe apex of the probe in the vagina is obtained by blowing up the twoposterior balloons on the probe. Next, the sleeve is slid along theprobe 310 to the precise position required to support the damagedligament. Alternatively, where the sleeve is more tightly fitting on thepessary, the sleeve can be prepositioned on the pessary prior toinsertion. The balloon on the sleeve is then inflated. The distance froma fixed marker on the pessary probe to the auxiliary balloon can benoted. The amount of fluid required can also be noted.

In a particular treatment method, the positioning is determined so thata sleeve with auxiliary balloon is positioned within the vaginal cavityimmediately in front of the cervix 132. After the pessary is inserted,the primary balloons are independently inflated to provide support forthe USL and the supplemental balloon is inflated to provide supplementalsupport to the CL. When use of the pessary is no longer desired, theballoons are deflated and the pessary removed from the vagina.

In variations of a method of treatment, the auxiliary balloon ispositioned on the probe to provide mechanical support for back, middle,or front ligaments for treatment of various conditions, such as thosedetailed in FIG. 2. Thus, in various examples, (i) in a method fortreatment of rectocoele, uterine/apical prolapse, abnormal emptying,frequency and urgency, nocturia, faecal incontinence, obstructeddefecation, or pelvic pain, the auxiliary balloon is positioned toprovide support for back ligaments (such as the USL and PB); (ii) in amethod for treatment of cystocoele, abnormal emptying, frequency andurgency, and tethered vagina, the auxiliary balloon is positioned toprovide support for middle ligaments (such as the ATFP and CL); and(iii) in a method for treatment of stress incontinence, frequency andurgency, and faecal incontinence, the auxiliary balloon is positioned toprovide support for front ligaments (such as the PUL) and posteriorlyfor rectocele and descending perineal syndrome. In a variation of thetreatment method more than one auxiliary balloon can be used to providesupport for multiple different ligaments.

According to an additional embodiment, a method of performingelectromyography (EMG) assessment and/or muscle stimulation comprisesinserting (e.g., by a physician) a pessary, such as pessary 500 as inFIG. 5A, into the vagina to place the inflatable portions of the pessarybehind the cervix. This may entail inserting the pessary its fullestextent or inserting it less than the full amount. These balloons areindependently inflated an amount sufficient to hold the pessary inposition. Sensors mounted on the pessary detect internal electricalsignals which are carried by wires to an EMG sensing system that canrecord the signals, translate these signals into graphs, sounds ornumerical values. The output values can be interpreted by a specialistor for use in while performing other procedures.

The EMG sensors can be mounted on the inflatable portions 525, 525′ ofthe pessary and the step of inflation of these portions performed toposition the EMG electrodes in a desired location, such as directly overthe pelvic muscles on each side of the vagina. The method can includethe step of receiving the pessary and then attaching EMG sensors thepessary prior to the procedure, such as by adhesive or via a slidingsleeve 560. Other steps include positioning one or more EMG sensorselsewhere on the pessary, in addition to or as an alternative to EMBsensors associated with inflatable portions 525, 525′. Such sensors canbe placed on the body of the probe or on sleeves fitted over the probe,and could be provided with or attached to auxiliary balloon sleeves asdiscussed, e.g., with respect to FIG. 6A.

In a further method, in addition to or as an alternative to EMG sensors,muscle stimulation electrodes are attached to the pessary in a mannersimilar to that addressed above for EMG sensors. The pessary isinserted, inflated to secure the pessary in place and, where theelectrodes are on an inflatable portion the position of the electrodesis adjusted as may be required. Electrical signals are then applied tothe electrode to stimulate the muscles adjacent the electrodes. In aparticular method, the muscle stimulation electrodes are attached to ormounted over the inflatable portions 525, 525′ and inflation is used toposition the electrodes over the pelvic muscles on each side, such asthe pubococcygeus muscles, and then electrical signals are applied tostimulate these muscles. Other steps include positioning one or moreelectrodes for muscle stimulation elsewhere on the pessary, in additionto or as an alternative muscle stimulation electrodes associated withinflatable portions 525, 525′. Such sensors can be placed on the body ofthe probe or on sleeves fitted over the probe, and could be provide withor attached to auxiliary balloon sleeves as discussed, e.g., withrespect to FIG. 6A.

It should be appreciated that the method can include both EMG sensingand muscle stimulation and that these activities can be performed insequence or at the same time, and that they can use the same ordifferent electrodes.

Various aspects, embodiments, and examples of pessaries and methods foruse have been disclosed and described herein. Modifications, additionsand alterations may be made by one skilled in the art without departingfrom the spirit and scope of the inventions as defined in the appendedclaims.

1. A pessary system for providing pelvic floor ligament supportcomprising: An elongated probe extending along a longitudinal axis andconfigured for insertion into a vaginal cavity, the probe having aninsertion end and a distal end; a sleeve having a body extending alongthe longitudinal axis with a forward part of the sleeve closest to theinsertion end and respective first and second side apertures in the bodyof the sleeve and distal to the forward part of the sleeve, a firstinflatable portion substantially a first distance from the insertion endand adjacent the first side aperture; a second inflatable portionsubstantially the first distance from the insertion and adjacent thesecond side aperture; at least one conduit in fluid communication withthe first inflatable portion and the second inflatable portion, thefirst and second inflatable portions being inflatable using fluidintroduced through the at least one conduit; wherein inflation of thefirst and second inflatable portions is constrained by the sleeve andthe first inflatable portion when inflated expands laterally away fromthe longitudinal axis through the first aperture and into a first radialsector and the second inflatable portion when inflated expands laterallyaway from the longitudinal axis through the second aperture and into asecond radial sector.
 2. The system of claim 1, wherein the first andsecond sectors are spaced apart from each other.
 3. The system of claim1, wherein a mid-line of the first sector and a mid-line of the secondsector are between 90 and 180 degrees apart.
 4. (canceled)
 5. The systemof claim 1, the at least one conduit comprising first and secondconduits, the first conduit comprising a first elongated tube having thefirst inflatable portion formed therein and the second conduitcomprising a second elongated tube having the second inflatable portionformed therein.
 6. The system of claim 5, wherein the first inflatableportion is a balloon portion of a first balloon catheter and the firstconduit is a tube portion of the first balloon catheter; the secondinflatable portion is a balloon portion of a second balloon catheter andthe second conduit is a tube portion of the first balloon catheter; 7.The system of claim 1, wherein the sleeve is an outer sleeve.
 8. Thesystem of claim 1, wherein each of the first and second inflatableportions is configured, respectively, to expand when inflated a firstinflation distance towards the distal end of the probe and a secondinflation distance towards the insertion end of the probe and differentfrom the first inflation distance.
 9. The system of claim 30, furthercomprising first and second lumens connected respectively to the firstand second conduits, and to each of which a source of a measured amountof fluid can be connected.
 10. The system of claim 30 further comprisinga lumen to which a source of a measured amount of fluid can beconnected; and a valve configured to selectively connect the lumen toeach of the first conduit and the second conduit; wherein the first andsecond inflatable portions are independently inflatable by fluidintroduced through the lumen.
 11. The system of claim 30, furthercomprising first and second syringes removably connected respectively tothe first and second fluid conduits to allow injection of a measuredamount of fluid into the respective first and second conduits.
 12. Thesystem of claim 11, wherein the first and second syringes are adjustableconstant volume syringes coupled to each other.
 13. The system of claim1, further comprising a circumferential inflatable portion and a thirdfluid conduit in fluid communication with the circumferential inflatableportion, the circumferential inflatable portion at a second distancefrom the insertion end of the probe greater than the first distance, thecircumferential inflatable portion being inflatable independently fromthe first and second inflatable portions.
 14. The system of claim 1,further comprising an electromyography sensor mounted to the firstinflatable portion.
 15. The system of claim 1, further comprising amuscle stimulation electrode mounted to the first inflatable portion.16. The system of claim 1 further comprising an inflatable sleeveslidably engaged on an outer wall of the probe and movable along thelongitudinal axis.
 17. (canceled)
 18. (canceled)
 19. A customizablepessary system for providing pelvic floor ligament support andcomprising: an elongated probe extending along a longitudinal axis andconfigured for insertion into a vaginal cavity, the probe having aninsertion end and a distal end; a first pair of inflatable portionscomprising inflatable respective left and right side portions eachlocated along the probe a first distance distally from the insertion endand configured to expand laterally from the probe relative to thelongitudinal axis when inflated; a second pair of inflatable portionscomprising inflatable respective left and right side portions eachlocated along the probe a second distance distally from the insertionend and configured to expand laterally from the probe relative to thelongitudinal axis when inflated; and a sleeve having a body andconfigured to be adjustably positioned on the probe along thelongitudinal axis to a first position in which the first pair ofinflatable portions is exposed and the second pair of inflatableportions are covered by the body of the sleeve and wherein the sleeveblocks inflation of the second pair of inflatable portions beyond thesleeve, and to a second position in which the second pair of inflatableportions is exposed and the first pair of inflatable portions arecovered by the body of the sleeve and wherein the sleeve blocksinflation of the first pair of inflatable portions beyond the sleeve.20. The system of claim 19, wherein the left portions of the first andsecond pairs of inflatable portions are connected to a common leftinflation conduit and the right portions of the first and second pairsof inflatable portions are connected to a common right inflationconduit, wherein the left portions of the first and second pairs ofinflatable portions can be inflated independently of the right portionsof the first and second pairs of inflatable portions.
 21. The system ofclaim 19, the sleeve comprising at least one side aperture spaceddistally from a front of the sleeve, and wherein in the first positionthe first pair of inflatable portions is exposed through the at leastone side aperture and in the second position the second pair ofinflatable portions is exposed through the at least one side aperture;wherein when a respective pair of inflatable portions is exposed throughthe at least one side aperture and inflated, the left and right sideportions of the respective pair of inflatable portions expand outwardsthrough the at least one side aperture into non-overlapping radialsectors relative to the longitudinal axis of the probe.
 22. A method forproviding support to pelvic floor ligaments of a patient having avaginal cavity with an apex, the method comprising the steps of:providing a pessary comprising an elongated probe extending along alongitudinal axis, the probe having an insertion end, a distal end, andfirst and second inflatable balloons each located substantially a firstdistance from the insertion end, the first and second balloonsinflatable through at least one conduit and configured to expand wheninflated into respective non-overlapping first and second radialsectors; inserting the probe into the vaginal cavity of the patient to atreatment position placing the first and second balloons within the apexof the vaginal cavity and oriented so that when the first and secondballoons are inflated, each balloon will provide ligament support to arespective pelvic floor ligament, wherein when the patent is one with acervix the first and second balloons are positioned behind the cervix;inflating the first and second balloons to provide ligament support on afirst lateral side of the patient by the first balloon and to provideligament support on a second lateral side of the patient by the secondballoon.
 23. The method of claim 22, wherein the respective pelvic floorligaments are first and second USLs; the step of inflating the firstballoon comprising inflating the first balloon to position the firstballoon below the first USL on the first lateral side of the patient tosupport the first USL; and the step of inflating the second ballooncomprising inflating the second balloon to position the second balloonbelow the second USL on the second lateral side of the patient tosupport the second USL.
 24. The method of claim 22, wherein the firstand second balloons are independently inflatable, the method furthercomprising the steps of: determining a first volume of fluid needed toinflate the first balloon a first amount to provide the ligament supporton the first lateral side of the patient; determining a second volume offluid needed to inflate the second balloon a second amount to providethe ligament support on the second lateral side of the patient;recording the first and second volumes; deflating first and secondballoons and then and removing the probe from the vaginal cavity;reinserting the probe into the vaginal cavity substantially to thetreatment position; reinflating the first balloon by injecting the firstvolume of fluid into the first conduit to provide the ligament supporton the first lateral side of the patient; and reinflating the secondballoon by injecting the second volume of fluid into the second conduitto provide the ligament support on the second lateral side of thepatient.
 25. The method of claim 22, the pessary further comprising anauxiliary balloon positioned on the probe an auxiliary second distancefrom the insertion end that is further than the first distance, theauxiliary balloon inflatable independently of the first and secondballoons; the insertion position putting the auxiliary balloon withinthe vaginal cavity distal to the apex; the method further comprising thestep of inflating the auxiliary balloon after the first and secondballoons are inflated, wherein the inflated auxiliary balloon providesauxiliary ligament support.
 26. The method of claim 25, wherein theinflated first and second balloons provide support for respective firstand second USLs of the patient and the auxiliary balloon providessupport for a CL of the patient.
 27. The method of claim 25, theauxiliary balloon comprising a movable sleeve on the probe; the methodfurther comprising the step of moving the sleeve to adjust the auxiliarydistance.
 28. (canceled)
 29. (canceled)
 30. The system of claim 1,wherein the at least one conduit comprises a first conduit in fluidcommunication with the first inflatable portion and a second conduit influid communication with the second inflatable portion, the first andsecond inflatable portions being independently inflatable.
 31. Thesystem of claim 1, wherein the first inflatable portion and secondinflatable portions are first and second portions of a common balloon.32. The system of claim 19, wherein the left side portion of the firstpair of inflatable portions is inflatable independently of the rightside portion of the first pair of inflatable portions, and the left sideportion of the second pair of inflatable portions is inflatableindependently of the right side portion of the second pair of inflatableportions.
 33. The method of claim 22, the provided pessary furthercomprising a sleeve extending along the longitudinal axis and having abody surrounding the first and second inflatable portions, the sleevehaving a forward part closest to the insertion end and respective firstand second side apertures distal to the forward part, each apertureadjacent a respective inflatable portion; wherein during the step ofinflating the first balloon, the first balloon expands outward from thepessary through the first side aperture; and during the step ofinflating the second balloon, the second balloon expands outward fromthe pessary through the second side aperture.
 34. The method of claim22, wherein the first and second balloons are independently inflatable,the step of inflating the first and second balloons comprising inflatingthe first balloon a first amount and inflating the second balloon asecond amount that different from the first amount.